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Responsibilities:

• Fully support the Quality needs of the Service Depot, Field Service, failure analysis and post market analysis teams. This includes validation support and nonconformance documentation.

• Conduct risk assessments on product and process nonconformance's to determine patient/user health risk; develop and document action plan to address discrepancies.

• Provide oversight and approval of NC & CAPA, and mentor in problem solving and root causing activities.

• Drive continuous improvement in the Quality Assurance area, including cost reduction opportunities.

• Work collaboratively with operations & strategic partners, such as Manufacturing, Engineering, and Supply Planning to achieve strategic initiatives.

• Provide input for product development of serviceable product; support validation of new equipment and fixtures; create new quality inspection procedures for product acquisitions intended to be serviced.

• Facilitate and lead teams of subject matter experts to generate technical documentation as appropriate.

• Review and comprehend applicable Quality System Procedures, ensuring compliance to the procedures. Create or update procedures as necessary.

• Prepare monthly presentations for cross-department assessment utilizing various sources of data from ERP systems, complaint databases and customer feedback.

• Prioritize and manage multiple projects within process/design specifications and budget restrictions.

• Responsible for initiation, management and support of Product Holds, as well as potential product escapes.

• Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description for areas of expertise.

Requirements:

• Bachelor's Degree in Engineering is required

• 2+ years' experience in engineering, quality, manufacturing, or highly regulated environment.

• Experience in the medical device industry.

• Knowledge of FDA, ISO and other regulations and standards preferred.

• Knowledge of automation process, continuous improvement and lean manufacturing.

• Knowledge of Risk Analysis, Root Cause Analysis, Statistics and practical applications preferred.

• ASQ Certifications (CQE, CRE, CQM, CSSBB) preferred.